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Providence Clinical Research Associate II - Regulatory in Santa Monica, California


Providence is calling a Clinical Research Associate II - Regulatory for a Full-Time/Day Shift to Saint John's Cancer Institute in Santa Monica, CA

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We are seeking a Clinical Research Coordinator II - Regulatory who will coordinate all of the regulatory documents including, but not limited to the protocol, informed consents, 1572s, financial disclosures, investigator CVs, training certificates and other documents as appropriate to all research activities across the California Region. Independently responsible for, but not limited to, drafting all IRB application submissions for new protocols, consents, amendments, renewals, safety reports from sponsors, and website postings/advertisements for submission to the Providence IRB per federal regulations. Ensures that all regulatory documents are in compliance and maintained in accordance with ICH/GCP and FDA guidelines. Works independently to assure compliance with the requests of sponsors, IRB and internal managers and directors as needed. Works with Clinical CRAs/CRNs in conducting monitoring visits, responding to monitoring/audit reports and additional research protocol duties as needed. Maintain sponsor, investigator and research personnel regulatory communication and serve as primary contact for all IRB and regulatory correspondence with sponsors and cooperative groups. Duties include assistance with grant preparation, IND applications, contracts and budget preparation. Must uphold the standards of confidentiality, attendance and punctuality. Performs all duties in a manner which promotes team concept and reflects the Sisters of Providence mission and philosophy.

In this position you will:

  • Initiate all IRB submissions: new protocols, amendments, renewals and closures. Completes all IRB submission forms and letters and serves as liaison between IRB and Sponsors, as appropriate, during IRB approval process. Responsible for all responses to post-I RB review correspondence. Ensures effective communication of new approvals, amendments and closures post !RB-review to all internal and external stakeholders.

  • Responsible for drafting all study Informed Consent Forms in compliance with IRB form templates and procedures. Maintains all IRB form templates in conjunction with evolving language set forth by IRB, including maintaining the glossary of terms for IRB consent forms. Drafts and submits AE/SAEs in accordance with Sponsor and IRB timelines. Files and submits IND safety reports to the IRB if they meet IRB reporting requirements. Works with clinical CRAs/CRNs to obtain accurate information as needed.

  • Assist in the development and preparation of Investigator Initiated Trials (IIT).

  • Compile regulatory submissions of IND applications, including annual reviews and communication of significant amendments.

  • Prepare and/or oversees all the regulatory submissions for grant applications.

  • Conduct quality reviews of regulatory documents to ensure compliance.

  • Assist in the process of contract and budgeting as requested.

  • Serve as liaison and assists with study specific site questionnaires, CDAs and CT As; maintains protocol pipeline log and communicates with Sponsors as appropriate to expedite all pre- IRB submission processes.

  • Assure that all the open protocols, informed consents, 1572s, and financial disclosures are in compliance with all regulatory standards. This includes, but is not limited to, FDA, DHHS, OHRP, and the IRB.

  • Maintain current study forms, training documents and signature logs for all studies; current CVs and licenses for all physicians; CLIA, and CAP licenses, and a current list of Open, Closed and Pending Studies both internally and externally via website.

  • Assure annual renewal of all appropriate studies, financial disclosures of all physicians for all studies and physician memberships to all applicable sponsors, CTSU, cooperative groups and NCI.

  • Maintain all research Excel spreadsheets, research databases and protocol/pocket cards for all staff and MDs. This includes maintaining protocol life-cycle tracking and maintaining all in-coming and outgoing financial records for contract/industry sponsored studies.

  • Maintain regulatory data requested by the sponsor, investigator/research personnel and IRB, FDA and all applicable regulatory agencies. Drafts and maintains all Regulatory Department Guidelines accordingly.

  • Responsible for communicating sponsor broadcasts and any study-specific communications from Sponsors to the clinical CRA/CRN staff for updates on new study-related forms, study amendments, updates and closures.

Required qualifications for this position include:

  • Bachelor's Degree in related field or equivalent educ/experience

  • Three (3) years experience

  • Proficient in Good Clinical Practices

  • Contract, budgeting and grant processing

  • Proficient in Medical Terminology

  • Knowledge of Institutional Review Board (IRB) requirements

  • Familiar with ICH/GCP, FDA, and IRB guidelines 1

  • Demonstrates knowledge of computer software applications

  • Organized and detail oriented

  • Ability to function independently and assertively in a collaborative environment

Preferred qualifications for this position include:

  • SOCRA/ACRP clinical research certification

  • 3 years experience in clinical research regulatory, oncology

About the hospital you will serve:

The John Wayne Cancer Institute at Providence Saint John’s Health Center is a cancer research institute dedicated to the understanding and curing of cancer in order to eliminate patient suffering worldwide. The Institute's mission is accomplished by conducting innovative research focused on biological mechanisms to provide new understandings of the cause, diagnosis, control, and cure of cancer; training the next generation of surgical scientists who study and treat cancer; and researching unique experimental treatment services to rapidly develop and test new forms of diagnosis and therapy in order to improve the quality of life and expected survival of those afflicted with cancer.

About Providence

At Providence, our strength lies in Our Promise of “Know me, care for me, ease my way.” Working at our family of organizations means that regardless of your role, we’ll walk alongside you in your career, supporting you so you can support others. We provide best-in-class benefits and we foster an inclusive workplace where diversity is valued, and everyone is essential, heard and respected. Together, our 120,000 caregivers (all employees) serve in over 50 hospitals, over 1,000 clinics and a full range of health and social services across Alaska, California, Montana, New Mexico, Oregon, Texas and Washington. As a comprehensive health care organization, we are serving more people, advancing best practices and continuing our more than 100-year tradition of serving the poor and vulnerable.

Requsition ID: P340161
Company: Providence Jobs
Job Category: Research
Job Function: Clinical Support
Schedule: Full time
Shift: Day
Career Track: Clinical Support
Department: 7009 SJCI LA Regl Sponsored Projects Administration
Address: CA Santa Monica 2200 Santa Monica Blvd

Providence is proud to be an Equal Opportunity Employer. Providence does not discriminate on the basis of race, color, gender, disability, veteran, military status, religion, age, creed, national origin, sexual identity or expression, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law.